(Albany, New York) – November 13, 2026: DelveInsight’s “Osteoporosis Market Insights, Epidemiology, and Market Forecast-2036″ report offers an in-depth understanding of the Osteoporosis, historical and forecasted epidemiology as well as the Osteoporosis market trends in the United States, EU4 (Germany, Spain, Italy, France) the United Kingdom and Japan.
The latest healthcare forecast report provides an in-depth analysis of Osteoporosis, offering comprehensive insights into the Osteoporosis revenue trends, prevalence, and treatment landscape. The report delves into key Osteoporosis statistics, highlighting the current and projected market size, while examining the efficacy and development of emerging Osteoporosis therapies. Additionally, we cover the landscape of Osteoporosis clinical trials, providing an overview of ongoing and upcoming studies that are poised to shape the future of Osteoporosis treatment. This report is an essential resource for understanding the market dynamics and the evolving therapeutic options within the Osteoporosis space.
To Know in detail about the Osteoporosis market outlook, drug uptake, treatment scenario and epidemiology trends, Click here; Osteoporosis Market Forecast
Some of the key facts of the Osteoporosis Market Report:
The Osteoporosis market size is anticipated to grow with a significant CAGR during the study period (2022-2036).
In November 2026, Entera Bio reported that preparations for the Phase III clinical study of EB613 were progressing, with the activation of the first clinical site expected in late 2026. EB613 is an investigational oral PTH(1-34) tablet being developed for post
In September 2026, he US FDA approved Teva’s DEGEVMA, a biosimilar to Xgeva (denosumab). It is indicated for certain cancer-related bone complications, giant cell tumor of bone, and hypercalcemia of malignancy. Although this approval expands denosumab biosimilar availability, DEGEVMA is not an osteoporosis treatment indication.
In August 2026, A 12-month Phase III study involving 279 postmenopausal women with osteoporosis evaluated KN012 against reference denosumab. Published findings demonstrated equivalent lumbar spine BMD outcomes, with comparable safety, pharmacokinetics, bone turnover markers, and immunogenicity profiles. The findings support the potential of KN012 as a biosimilar treatment option for osteoporosis.
In July 2026, reports highlighted Phase III findings for KN012, a denosumab biosimilar, demonstrating comparable bone mineral density outcomes to reference denosumab in postmenopausal women with osteoporosis in China. The findings support further development of biosimilar alternatives in osteoporosis management.
In March 2026, Entera Bio submits a streamlined Phase III Protocol to initiate a registrational program for EB613 in Postmenopausal Women with Osteoporosis; Entera commits to a 12-month extension study to run in parallel with potential NDA review.
In March 2026, the US FDA approved Teva Pharmaceuticals’ PONLIMSI as an interchangeable biosimilar to Prolia (denosumab). It is indicated for postmenopausal women and men with osteoporosis at high risk of fractures, among other bone-related indications. The approval expands treatment options and could improve access to denosumab-based osteoporosis management.
In January 2026, Angita Biopharmaceuticals completes enrollment in Phase II (ARTEMIS) trial of AGA2118 for Osteoporosis treatment; topline data expected in 2027.
In September 2025, Shanghai Henlius Biotech and Organon announced that the U.S. FDA approved BILDYOS® (denosumab-nxxp) injection 60 mg/mL and BILPREVDA® (denosumab-nxxp) injection 120 mg/1.7 mL, biosimilars to PROLIA and XGEVA, respectively, for all indications of the reference products. BILDYOS is a RANK ligand (RANKL) inhibitor indicated for osteoporosis treatment in high-risk postmenopausal women and men, glucocorticoid-induced osteoporosis, and bone mass increase in prostate and breast cancer patients receiving specific therapies. Patients with advanced kidney disease face higher risks of severe hypocalcemia, requiring expert supervision before and during treatment.
In September 2025, Naitive Technologies announced that it received 510(k) clearance from the U.S. FDA for its AI-driven product, OsteoSight. This software enables bone mineral density (BMD) assessment using standard X-rays, helping detect osteoporosis earlier, which is often undiagnosed until fractures occur. OsteoSight supports proactive osteoporosis management and offers growth opportunities for orthopedic practices.
In March 2025, the FDA approved Fresenius Kabi Biopharma’s denosumab biosimilars, Conexxence and Bomyntra (denosumab-bnht), for all indications of the reference products Prolia and Xgeva, expanding access to more affordable treatments for osteoporosis, bone metastases, and other bone-related conditions.
In March 2025, Dr. Reddy’s Laboratories Ltd. and Alvotech announced that the FDA has accepted a 351(k) Biologic License Application (BLA) submission for AVT03, a proposed biosimilar of Prolia® (denosumab) and Xgeva® (denosumab), developed by Alvotech.
In March 2025, Celltrion announced that the U.S. Food and Drug Administration (FDA) has approved STOBOCLO® (CT-P41, denosumab-bmwo) and OSENVELT® (CT-P41, denosumab-bmwo), biosimilars referencing PROLIA® (denosumab) and XGEVA® (denosumab), respectively, for all indications of the reference products.
As per the National Institute of Health Osteoporosis and Related Bone Diseases National Resource Center, in the US, more than 53 million people either already have osteoporosis or are at high risk due to low bone mass. While, the National Health Service quotes that osteoporosis affects over 3 million people in the UK, wherein more than 500,000 people receive hospital treatment for fragility fractures every year as a result of osteoporosis.
In osteoporosis-related comorbidities, diabetes, respiratory disease, and cardiovascular diseases contributed the most in 2024.
As per the International Osteoporosis Foundation (2024), it is estimated that 75 million people in Europe, in the US, and Japan are affected by osteoporosis. In Asia, osteoporosis is greatly underdiagnosed and under-treated, even in the highest-risk patients who have already fractured.
Key Osteoporosis Companies: Amgen and UCB, EnteraBio, Rani Therapeutics, Lactocore, Rani Therapeutics, Jiangsu HengRui Medicine, Levolta Pharmaceuticals, Inc., Celltrion, Teva Pharmaceuticals, and others
Key Osteoporosis Therapies: EVENITY (romososzumab), EB613 (PTH 1-34), RT-102, Research programme, RT-102, SHR-1222, VOLT01, CT-P41, TVB-009, and others
The Osteoporosis market is expected to surge due to the disease’s increasing prevalence and awareness during the forecast period. Furthermore, launching various multiple-stage Osteoporosis pipeline products will significantly revolutionize the Osteoporosis market dynamics.
As per the International Osteoporosis Foundation, Osteoporosis affected approximately 5.2% of the total population in the UK, closely aligning with the EU27+2 average of 5.6%. Among individuals aged 50 and above in the UK, it was estimated that 21.9% of women and 6.7% of men had Osteoporosis. Hip fractures are considered the most severe outcome of the disease due to their significant impact on health, mortality, and healthcare costs.
A study by Yoshimura et al. (2022) reported that in Japan, the prevalence of lumbar spine (L2–L4) osteoporosis was 13.6% at the initial survey (3.4% in men and 19.2% in women) and dropped significantly to 9.7% at the fourth survey (1.4% in men and 13.9% in women), with the difference being statistically significant (p < 0.01). However, no significant change was observed in the prevalence of femoral neck osteoporosis between the two surveys.
Osteoporosis Overview
Osteoporosis is a medical condition in which bones become weak, brittle, and more prone to fractures due to a loss of bone density and strength. It often develops silently over time and is most common in older adults, especially postmenopausal women. Common fracture sites include the hip, spine, and wrist. The condition can be managed or prevented through calcium and vitamin D intake, regular weight-bearing exercise, and medications that help strengthen bones.
Get a Free sample for the Osteoporosis Market Forecast, Size & Share Analysis Report:
https://www.delveinsight.com/report-store/osteoporosis-market
Osteoporosis Epidemiology
The Osteoporosis epidemiology section provides insights into the historical, current, and forecasted epidemiology trends in the seven major countries (7MM) from 2022 to 2036. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. The epidemiology section also provides a detailed analysis of the diagnosed patient pool and future trends.
Osteoporosis Epidemiology Segmentation:
The Osteoporosis market report proffers epidemiological analysis for the study period 2022–2036 in the 7MM segmented into:
Prevalent Cases of Osteoporosis
Diagnosed Prevalent Cases of Osteoporosis
Gender-specific Prevalent Cases of Osteoporosis
Age-specific Prevalent Cases of Osteoporosis
Treatable Cases of Osteoporosis
Download the report to understand which factors are driving Osteoporosis epidemiology trends @ Osteoporosis Epidemiology Forecast
Osteoporosis Drugs Uptake and Pipeline Development Activities
The drugs uptake section focuses on the rate of uptake of the potential drugs recently launched in the Osteoporosis market or expected to get launched during the study period. The analysis covers Osteoporosis market uptake by drugs, patient uptake by therapies, and sales of each drug.
Moreover, the therapeutics assessment section helps understand the drugs with the most rapid uptake and the reasons behind the maximal use of the drugs. Additionally, it compares the drugs based on market share.
The report also covers the Osteoporosis Pipeline Development Activities. It provides valuable insights about different therapeutic candidates in various stages and the key companies involved in developing targeted therapeutics. It also analyzes recent developments such as collaborations, acquisitions, mergers, licensing patent details, and other information for emerging therapies.
Osteoporosis Therapies and Key Companies
EVENITY (romososzumab): Amgen and UCB
EB613 (PTH 1-34): EnteraBio
RT-102: Rani Therapeutics
Research programme: Lactocore
SHR-1222: Jiangsu HengRui Medicine
VOLT01: Levolta Pharmaceuticals, Inc.
CT-P41: Celltrion
TVB-009: Teva Pharmaceuticals
Discover more about therapies set to grab major Osteoporosis market share @ Osteoporosis Treatment Landscape
Osteoporosis Market Drivers
Rising Prevalence of Osteoporosis: The increasing global geriatric population, growing life expectancy, and rising incidence of age-related bone disorders are driving demand for effective osteoporosis treatment and management.
Increasing Awareness and Early Diagnosis: Growing awareness of bone health, expanding screening initiatives, and the adoption of bone mineral density (BMD) testing are supporting early diagnosis and treatment initiation.
Advancements in Novel Therapeutics: The development of innovative therapies, including anabolic agents, monoclonal antibodies, and next-generation bone-forming drugs, is expanding treatment options for osteoporosis patients.
Growing Focus on Fracture Prevention: Increasing emphasis on preventing osteoporosis-related fractures, particularly hip and vertebral fractures, is encouraging the adoption of effective pharmacological interventions.
Expanding Clinical Pipeline and R&D Investments: Rising investments in clinical research and the development of novel drugs with improved efficacy, safety, and dosing convenience are creating new growth opportunities in the osteoporosis market.
Osteoporosis Market Barriers
High Treatment Costs: The cost of advanced biologics, injectable therapies, diagnostic procedures, and long-term disease management can limit treatment accessibility, particularly in developing economies.
Lack of Awareness and Underdiagnosis: Limited awareness of osteoporosis risk factors, inadequate screening, and delayed diagnosis often prevent timely intervention, increasing the risk of severe fractures.
Adverse Effects Associated with Existing Therapies: Potential complications associated with long-term osteoporosis treatments, including atypical femoral fractures, osteonecrosis of the jaw, and gastrointestinal adverse events, may affect treatment adherence.
Poor Treatment Compliance: The requirement for prolonged treatment, complex dosing schedules, and inadequate patient adherence can reduce therapeutic effectiveness and negatively impact disease management.
Regulatory and Clinical Development Challenges: The need for long-term clinical studies to demonstrate fracture risk reduction, along with stringent regulatory requirements and safety monitoring, can increase development costs and delay the introduction of novel therapies.
Scope of the Osteoporosis Market Report
Study Period: 2022–2036
Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan]
Osteoporosis Therapeutic Assessment: Osteoporosis current marketed and Osteoporosis emerging therapies
Osteoporosis Market Dynamics: Osteoporosis market drivers and Osteoporosis market barriers
Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter’s five forces, BCG Matrix, Market entry strategies
Osteoporosis Unmet Needs, KOL’s views, Analyst’s views, Osteoporosis Market Access and Reimbursement
To know more about Osteoporosis companies working in the treatment market, visit @ Osteoporosis Clinical Trials and Therapeutic Assessment
Table of Contents
1. Osteoporosis Market Report Introduction
2. Executive Summary for Osteoporosis
3. SWOT analysis of Osteoporosis
4. Osteoporosis Patient Share (%) Overview at a Glance
5. Osteoporosis Market Overview at a Glance
6. Osteoporosis Disease Background and Overview
7. Osteoporosis Epidemiology and Patient Population
8. Country-Specific Patient Population of Osteoporosis
9. Osteoporosis Current Treatment and Medical Practices
10. Osteoporosis Unmet Needs
11. Osteoporosis Emerging Therapies
12. Osteoporosis Market Outlook
13. Country-Wise Osteoporosis Market Analysis (2022–2036)
14. Osteoporosis Market Access and Reimbursement of Therapies
15. Osteoporosis Market Drivers
16. Osteoporosis Market Barriers
17. Osteoporosis Appendix
18. Osteoporosis Report Methodology
19. DelveInsight Capabilities
20. Disclaimer
21. About DelveInsight
About DelveInsight
DelveInsight is a leading Healthcare Business Consultant, and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance.
It also offers Healthcare Consulting Services, which benefits in market analysis to accelerate the business growth and overcome challenges with a practical approach.
Media ContactCompany Name: DelveInsightContact Person: Gaurav BoraEmail: Send EmailPhone: +14699457679Address:304 S. Jones Blvd #2432 City: Las VegasState: NV 89107Country: United StatesWebsite: https://www.delveinsight.com/consulting/due-diligence-services
